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This is a single arm, Open-Label, Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light Chain (AL) Amyloidosis.
A Single Arm, Open-Label, Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light Chain (AL) Amyloidosis. The first part of the study is phase 1 dose-escalation and the second part will be phase 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Subjects will receive ZN-d5 orally (PO), once (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZN-d5 | Drug | ZN-d5 will be administered orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Incidence and severity of adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 | 18 Months |
| Dose limiting toxicities | Incidence of Dose-limiting toxicities (DLTs) observed in DLT evaluable subjects | 18 Months |
| Measure | Description | Time Frame |
|---|---|---|
| PK Parameter: Finding max concentration (Cmax) of ZN-d5 | Determine the maximum observed concentration (Cmax) of ZN-d5 collected in the plasma from subjects at different dose levels. | 48 months |
| PK Parameter: Finding time to maximum concentration (Tmax) of ZN-d5 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess potential biomarker of ZN-d5 | The number of peripheral B-Cells from blood tests | 48 months |
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Affairs | K-Group Alpha subsidiary of Zentalis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90089 | United States | ||
| Colorado Blood Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40226119 | Derived | Locke M, Nieto M. AL Amyloidosis: Current Treatment and Outcomes. Adv Hematol. 2025 Mar 3;2025:7280805. doi: 10.1155/ah/7280805. eCollection 2025. |
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The duration (in hours) it takes for ZN-d5 to reach the maximum concentration (or Cmax) collected in the plasma from subjects at different dose levels. |
| 48 months |
| PK Parameter: Finding half-life of ZN-d5 | The time takes for half the drug concentration of ZN-d5 to be eliminated (Half-life) from the plasma that was collected from subjects at different dose levels | 48 months |
| PK Parameter: Finding the Area Under the Curve (AUC) of ZN-d5 | The total exposure of ZN-d5 over time (AUC) from the plasma collected by the subject at different dose levels. | 48 months |
| Assess the hematologic response to ZN-d5 | The number of Complete Response (CR), Very Good Partial Response (VGPR), Partial Response (PR), No Response (NR), Progressive Disease (PD) using the AL Amyloidosis Hematologic Response Criteria. | 48 months |
| Duration and time to hematologic response to ZN-d5 | The rate of, duration of, and time to CR, modified Complete Response (mCR), CR+VGPR, and mCR+VGPR | 48 months |
| Denver |
| Colorado |
| 80218 |
| United States |
| Tulane University | New Orleans | Louisiana | 70112 | United States |
| Washington University | St Louis | Missouri | 63130 | United States |
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| Blackwater (Westmead) Hospital | Westmead | New South Wales | 2145 | Australia |
| Princess Alexandra Hospital | Brisbane | Queensland | 4102 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Sir Charles Gairdner Hospital | Nedlands | Western Australia | Australia |
| Bank of Cyprus Hospital | Nicosia | Cyprus |
| National and Kapodistrian University of Athens | Athens | 115 28 | Greece |
| Rambam Hospital | Haifa | 3109601 | Israel |
| Hadassah Medical Center | Jerusalem | Israel |
| Sheba Medical Center | Tel Aviv | Israel |
| Tel Aviv Sourasky Medical Center PPDS | Tel Aviv | Israel |
| IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola Malpighi | Bologna | Italy |
| Fondazione I.R.C.C.S. Policlinico San Matteo | Pavia | Italy |
| ICO Badalona-H.U. Germans Trias i Pujol | Barcelona | Badalona | Spain |
| Hospital ClĂnico Universitario Virgen de la Arrixaca | El Palmar | Murcia | 30120 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Clinico de Salamanca | Salamanca | Spain |
| ID | Term |
|---|---|
| D000686 | Amyloidosis |
| D000075363 | Immunoglobulin Light-chain Amyloidosis |
| ID | Term |
|---|---|
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D010265 | Paraproteinemias |
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| ID | Term |
|---|---|
| D004341 | Drug Evaluation |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
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